Peer providers and linkage with buprenorphine care after hospitalization: A retrospective cohort study.

Background: People with opioid use disorder (OUD) are increasingly started on buprenorphine in the hospital, yet many patients do not attend outpatient buprenorphine care after discharge. Peer providers, people in recovery themselves, are a growing part of addiction care. We examine whether patients who received a low-intensity, peer-delivered intervention during hospitalization had a greater rate of linking with outpatient buprenorphine care relative to those not seen by a peer. Methods: This was a retrospective cohort study of adults with OUD who were started on buprenorphine during hospitalization. The primary outcome was receipt of a buprenorphine prescription within 30 days of discharge. Secondary outcomes included attendance at a follow-up visit with a buprenorphine provider within 30 days and hospital readmission within 90 days. Modified Poisson regression analyses tested for differences in the rate ratios (RR) of each binary outcome for patients who were versus were not seen by a peer provider. Peer notes in the electronic health record were reviewed to characterize peer activities. Results: 111 patients met the study inclusion criteria, 31.5% of whom saw a peer provider. 55.0% received a buprenorphine prescription within 30 days of hospital discharge. Patients with versus without peer provider encounters did not significantly differ in the rates of receiving a buprenorphine prescription (RR = 1.06, 95% CI: 0.74-1.51), hospital readmission (RR = 1.45, 95% CI: 0.80-2.64), or attendance at a buprenorphine follow-up visit (RR = 1.03, 95% CI: 0.68-1.57). Peers most often listened to or shared experiences with patients (68.6% of encounters) and helped facilitate medical care (60.0% of encounters). Conclusions: There were no differences in multiple measures of buprenorphine follow-up between patients who received this low-intensity peer intervention and those who did not. There is need to investigate what elements of peer provider programs contribute to patient outcomes and what outcomes should be assessed when evaluating peer programs.

Prevalence and Medication Treatment of Opioid Use Disorder Among Primary Care Patients with Hepatitis C and HIV.

BACKGROUND: Hepatitis C and HIV are associated with opioid use disorders (OUD) and injection drug use. Medications for OUD can prevent the spread of HCV and HIV. OBJECTIVE: To describe the prevalence of documented OUD, as well as receipt of office-based medication treatment, among primary care patients with HCV or HIV. DESIGN: Retrospective observational cohort study using electronic health record and insurance data. PARTICIPANTS: Adults ≥ 18 years with ≥ 2 visits to primary care during the study (2014-2016) at 6 healthcare systems across five states (CO, CA, OR, WA, and MN). MAIN MEASURES: The primary outcome was the diagnosis of OUD; the secondary outcome was OUD treatment with buprenorphine or oral/injectable naltrexone. Prevalence of OUD and OUD treatment was calculated across four groups: HCV only; HIV only; HCV and HIV; and neither HCV nor HIV. In addition, adjusted odds ratios (AOR) of OUD treatment associated with HCV and HIV (separately) were estimated, adjusting for age, gender, race/ethnicity, and site. KEY RESULTS: The sample included 1,368,604 persons, of whom 10,042 had HCV, 5821 HIV, and 422 both. The prevalence of diagnosed OUD varied across groups: 11.9% (95% CI: 11.3%, 12.5%) for those with HCV; 1.6% (1.3%, 2.0%) for those with HIV; 8.8% (6.2%, 11.9%) for those with both; and 0.92% (0.91%, 0.94%) among those with neither. Among those with diagnosed OUD, the prevalence of OUD medication treatment was 20.9%, 16.0%, 10.8%, and 22.3%, for those with HCV, HIV, both, and neither, respectively. HCV was not associated with OUD treatment (AOR = 1.03; 0.88, 1.21), whereas patients with HIV had a lower probability of OUD treatment (AOR = 0.43; 0.26, 0.72). CONCLUSIONS: Among patients receiving primary care, those diagnosed with HCV and HIV were more likely to have documented OUD than those without. Patients with HIV were less likely to have documented medication treatment for OUD.

Staff Attitudes toward Buprenorphine before and after Implementation of an Office-Based Opioid Treatment Program in an Urban Teaching Clinic.

PURPOSE: Improving access to buprenorphine treatment is necessary to address the national opioid use disorder (OUD) crisis. This study investigates attitudes about buprenorphine prescribing among staff at a primary care clinic and compares attitudes before and after implementation of an office-based opioid treatment (OBOT) program. METHODS: Providers and staff in an academic primary care clinic were surveyed prior to and one year following implementation of an OBOT program. Descriptive statistics, Pearson's Chi-2 tests and logistic regression models were used to compare staff and provider attitudes about use of buprenorphine for OUD and to compare attitudes before and after OBOT implementation. RESULTS: At baseline, 20% of staff indicated strong belief that buprenorphine is an effective treatment for OUD and 16% indicated strong belief that primary care providers should prescribe it. Staff appeared less likely than providers to believe strongly that buprenorphine is effective (OR 0.24, 95% CI= 0.08-.78, p = 0.02; aOR 0.28, 95% CI=.08-1.0, p = 0.05 adjusted for age, race and gender). Following implementation of an OBOT program, the percentage of staff who believed strongly in the effectiveness of buprenorphine for OUD increased from 20% to 40% (p = 0.31), and the percentage who believed that primary care providers (PCPs) should prescribe it increased from 16% to 30% (p = 0.52). CONCLUSIONS: Staff in a primary care clinic were less likely than providers to believe in the effectiveness of buprenorphine treatment or that PCPs should prescribe it for OUD. That their beliefs substantially changed after implementation of an OBOT program suggests that direct experience impacts attitudes.

Mortality After Discontinuation of Primary Care-Based Chronic Opioid Therapy for Pain: a Retrospective Cohort Study.

BACKGROUND: Despite known risks of using chronic opioid therapy (COT) for pain, the risks of discontinuation of COT are largely uncharacterized. OBJECTIVE: To evaluate mortality, prescription opioid use, and primary care utilization of patients discontinued from COT, compared with patients maintained on opioids. DESIGN: Retrospective cohort study of patients with chronic pain enrolled in an opioid registry as of May 2010. PARTICIPANTS: Patients with chronic pain enrolled in the opioid registry of a primary care clinic at an urban safety-net hospital in Seattle, WA. MAIN OUTCOMES AND MEASURES: Discontinuation from the opioid registry was the exposure of interest. Pre-specified main outcomes included mortality, prescription and primary care utilization data, and reasons for discontinuation. Data was collected through March 2015. KEY RESULTS: The study cohort comprised 572 patients with a mean age of 54.9 ± 10.1 years. COT was discontinued in 344 patients (60.1%); 254 (73.8%) discontinued patients subsequently filled at least one opioid prescription in Washington State, and 187 (54.4%) continued to visit the clinic. During the study period, 119 (20.8%) registry patients died, and 21 (3.7%) died of definite or possible overdose: 17 (4.9%) discontinued patients died of overdose, whereas 4 (1.75%) retained patients died of overdose. Most patients had at least one provider-initiated reason for COT discontinuation. Discontinuation of COT was associated with a hazard ratio for death of 1.35 (95% CI, 0.92 to 1.98, p = 0.122) and for overdose death of 2.94 (1.01-8.61, p = 0.049), after adjusting for age and race. CONCLUSIONS: In this cohort of patients prescribed COT for chronic pain, mortality was high. Discontinuation of COT did not reduce risk of death and was associated with increased risk of overdose death. Improved clinical strategies, including multimodal pain management and treatment of opioid use disorder, may be needed for this high-risk group.

Effect of a Care Management Intervention on 12-Month Drinking Outcomes Among Patients With and Without DSM-IV Alcohol Dependence at Baseline.

BACKGROUND: The CHOICE care management intervention did not improve drinking relative to usual care (UC) for patients with frequent heavy drinking at high risk of alcohol use disorders. Patients with alcohol dependence were hypothesized to benefit most. We conducted preplanned secondary analyses to test whether the CHOICE intervention improved drinking relative to UC among patients with and without baseline DSM-IV alcohol dependence. METHODS: A total of 304 patients reporting frequent heavy drinking from 3 VA primary care clinics were randomized (stratified by DSM-IV alcohol dependence, sex, and site) to UC or the patient-centered, nurse-delivered, 12-month CHOICE care management intervention. Primary outcomes included percent heavy drinking days (%HDD) using 28-day timeline follow-back and a "good drinking outcome" (GDO)-abstaining or drinking below recommended limits and no alcohol-related symptoms on the Short Inventory of Problems at 12 months. Generalized estimating equation binomial regression models (clustered on provider) with interaction terms between dependence and intervention group were fit. RESULTS: At baseline, 59% of intervention and UC patients had DSM-IV alcohol dependence. Mean drinking outcomes improved for all subgroups. For participants with dependence, 12-month outcomes did not differ for intervention versus UC patients (%HDD 37% versus 38%, p = 0.76 and GDO 16% versus 16%, p = 0.77). For participants without dependence, %HDD did not differ between intervention (41%) and UC (31%) patients (p = 0.12), but the proportion with GDO was significantly higher among UC participants (26% versus 13%, p = 0.046). Neither outcome was significantly modified by dependence (interaction p values 0.19 for %HDD and 0.10 for GDO). CONCLUSIONS: Among participants with frequent heavy drinking, care management had no benefit relative to UC for patients with dependence, but UC may have had benefits for those without dependence. TRIAL REGISTRATION: ClinicalTrials.gov NCT01400581.

Impacts of an opioid overdose prevention intervention delivered subsequent to acute care.

BACKGROUND: Opioid overdose is a major and increasing cause of injury and death. There is an urgent need for interventions to reduce overdose events among high-risk persons. METHODS: Adults at elevated risk for opioid overdose involving heroin or pharmaceutical opioids who had been cared for in an emergency department (ED) were randomised to overdose education combined with a brief behavioural intervention and take-home naloxone or usual care. Outcomes included: (1) time to first opioid overdose-related event resulting in medical attention or death using competing risks survival analysis; and (2) ED visit and hospitalisation rates, using negative binomial regression and adjusting for time at risk. RESULTS: During the follow-up period, 24% of the 241 participants had at least one overdose event, 85% had one or more ED visits and 55% had at least one hospitalisation, with no significant differences between intervention and comparison groups. The instantaneous risk of an overdose event was not significantly lower for the intervention group (sub-HR: 0.83; 95% CI 0.49 to 1.40). DISCUSSION: These null findings may be due in part to the severity of the population in terms of housing insecurity (70% impermanently housed), drug use, unemployment and acute healthcare issues. Given the high overdose and healthcare utilisation rates, more intensive interventions, such as direct referral and provision of housing and opioid agonist treatment medications, may be necessary to have a substantial impact on opioid overdoses for this high-acuity population in acute care settings. TRIAL REGISTRATION NUMBER: NCT0178830; Results.

Interest in prescribing buprenorphine among resident and attending physicians at an urban teaching clinic.

Background: Opioid use disorders are a major medical and public health concern. Buprenorphine is approved for the treatment of opioid use disorders; however, a shortage of physicians prescribing buprenorphine is a significant barrier to treatment access. The aims of this study were to evaluate opinions of internal medicine attending and resident physicians about buprenorphine and assess interest in becoming waivered to prescribe. Methods: Internal medicine resident and attending physicians at a primary care clinic in a large academic hospital were invited to complete surveys. The study sample was composed of physicians who were not waivered to prescribe buprenorphine. Survey data included demographic information, level of training, buprenorphine waiver status, interest in becoming waivered to prescribe buprenorphine, and beliefs about buprenorphine for treatment of opioid use disorders. High interest in becoming waivered was defined as a Likert response >3 (1 = No interest, 5 = Very interested). Results: Of the 44 physician respondents, 39 were not waivered to prescribe buprenorphine and constituted the sample; of those, 27 were residents and 12 were attending physicians. Twenty-six of the 39 nonwaivered respondents (66.7%) had high interest in becoming waivered. Those with high interest in becoming waivered were significantly more likely to be younger (P = .007) and to strongly believe in buprenorphine effectiveness (P = .023). Discussion: Most physicians in this academic training program showed high interest in prescribing buprenorphine, and belief in buprenorphine effectiveness was associated with high interest in becoming waivered.

The Role of Current and Historical Alcohol Use in Hepatic Fibrosis Among HIV-Infected Individuals.

We examined risk factors for advanced hepatic fibrosis [fibrosis-4 (FIB)-4 >3.25] including both current alcohol use and a diagnosis of alcohol use disorder among HIV-infected patients. Of the 12,849 patients in our study, 2133 (17%) reported current hazardous drinking by AUDIT-C, 2321 (18%) had a diagnosis of alcohol use disorder, 2376 (18%) were co-infected with chronic hepatitis C virus (HCV); 596 (5%) had high FIB-4 scores >3.25 as did 364 (15%) of HIV/HCV coinfected patients. In multivariable analysis, HCV (adjusted odds ratio (aOR) 6.3, 95% confidence interval (CI) 5.2-7.5), chronic hepatitis B (aOR 2.0, 95% CI 1.5-2.8), diabetes (aOR 2.3, 95% CI 1.8-2.9), current CD4 <200 cells/mm3 (aOR 5.4, 95% CI 4.2-6.9) and HIV RNA >500 copies/mL (aOR 1.3, 95% CI 1.0-1.6) were significantly associated with advanced fibrosis. A diagnosis of an alcohol use disorder (aOR 1.9, 95% CI 1.6-2.3) rather than report of current hazardous alcohol use was associated with high FIB-4. However, among HIV/HCV coinfected patients, both current hazardous drinkers (aOR 1.6, 95% CI 1.1-2.4) and current non-drinkers (aOR 1.6, 95% CI 1.2-2.0) were more likely than non-hazardous drinkers to have high FIB-4, with the latter potentially reflecting the impact of sick abstainers. These findings highlight the importance of using a longitudinal measure of alcohol exposure when evaluating the impact of alcohol on liver disease and associated outcomes.

Prevalence and Factors Associated with Hazardous Alcohol Use Among Persons Living with HIV Across the US in the Current Era of Antiretroviral Treatment.

Hazardous alcohol use is associated with detrimental health outcomes among persons living with HIV (PLWH). We examined the prevalence and factors associated with hazardous alcohol use in the current era using several hazardous drinking definitions and binge drinking defined as ≥5 drinks for men versus ≥4 for women. We included 8567 PLWH from 7 U.S. sites from 2013 to 2015. Current hazardous alcohol use was reported by 27% and 34% reported binge drinking. In adjusted analyses, current and past cocaine/crack (odd ratio [OR] 4.1:3.3-5.1, p < 0.001 and OR 1.3:1.1-1.5, p < 0.001 respectively), marijuana (OR 2.5:2.2-2.9, p < 0.001 and OR 1.4:1.2-1.6, p < 0.001), and cigarette use (OR 1.4:1.2-1.6, p < 0.001 and OR 1.3:1.2-1.5, p < 0.001) were associated with increased hazardous alcohol use. The prevalence of hazardous alcohol use remains high in the current era, particularly among younger men. Routine screening and targeted interventions for hazardous alcohol use, potentially bundled with interventions for other drugs, remain a key aspect of HIV care.

Not all non-drinkers with HIV are equal: demographic and clinical comparisons among current non-drinkers with and without a history of prior alcohol use disorders.

Studies of persons living with HIV (PLWH) have compared current non-drinkers to at-risk drinkers without differentiating whether current non-drinkers had a prior alcohol use disorder (AUD). The purpose of this study was to compare current non-drinkers with and without a prior AUD on demographic and clinical characteristics to understand the impact of combining them. We included data from six sites across the US from 1/2013 to 3/2015. Patients completed tablet-based clinical assessments at routine clinic appointments using the most recent assessment. Current non-drinkers were identified by AUDIT-C scores of 0. We identified a prior probable AUD by a prior AUD diagnosis in the electronic medical record (EMR) or a report of attendance at alcohol treatment in the clinical assessment. We used multivariate logistic regression to examine factors associated with prior AUD. Among 2235 PLWH who were current non-drinkers, 36% had a prior AUD with more patients with an AUD identified by the clinical assessment than the EMR. Higher proportions with a prior AUD were male, depressed, and reported current drug use compared to non-drinkers without a prior AUD. Former cocaine/crack (70% vs. 25%), methamphetamine/crystal (49% vs. 16%), and opioid/heroin use (35% vs. 7%) were more commonly reported by those with a prior AUD. In adjusted analyses, male sex, past methamphetamine/crystal use, past marijuana use, past opioid/heroin use, past and current cocaine/crack use, and cigarette use were associated with a prior AUD. In conclusion, this study found that among non-drinking PLWH in routine clinical care, 36% had a prior AUD. We found key differences between those with and without prior AUD in demographic and clinical characteristics, including drug use and depression. These results suggest that non-drinkers are heterogeneous and need further differentiation in studies and that prior alcohol misuse (including alcohol treatment) should be included in behavioural health assessments as part of clinical care.

Mental Health Distress Is Associated With Higher Pain Interference in Patients With Opioid Use Disorder Stabilized on Buprenorphine or Methadone.

BACKGROUND: The relationships between opioid use disorder (OUD), chronic pain, and mental health distress are complex and multidirectional. The objective of this exploratory study was to examine the relationship between mental health conditions and Chronic pain severity and interference among patients stabilized on either buprenorphine or methadone. METHODS: We report baseline data from a randomized trial of a mind-body intervention conducted at 5 outpatient clinics that provided either buprenorphine or methadone treatment. Validated scales were used to measure substance use, mental health distress, and pain severity and interference. Statistical analyses examined the relationship between mental health conditions and pain severity and interference. RESULTS: Of 303 participants, 57% (n = 172) reported Chronic pain. A total of 88% (n = 268) were prescribed buprenorphine. Mental health conditions were common, with one-quarter of the sample screening positive for all 3 mental health conditions (anxiety, depression, and posttraumatic stress disorder [PTSD]). Compared to participants without Chronic pain, participants with Chronic pain were more likely to screen positive for moderate-severe anxiety (47% vs 31%); moderate-severe depression (54% vs 41%); and the combination of anxiety, depression, and PTSD (31% vs 18%). Among participants with Chronic pain, mental health conditions were associated with higher pain interference. Pain severity was higher among participants with mental health conditions, but only reached statistical significance for depression. Pain interference scores increased with a higher number of co-occurring mental health conditions. CONCLUSIONS: Among individuals stabilized on either buprenorphine or methadone, highly symptomatic and comorbid mental health distress is common and is associated with increased pain interference. Adequate screening for, and treatment of, mental health conditions in patients with OUD and Chronic pain is needed.

Immediate Effects of Mindful Awareness in Body-oriented Therapy as an Adjunct to Medication for Opioid Use Disorder.

Objective: While effective, medication for opioid use disorder (MOUD) treatment outcomes can be limited by co-occurring polysubstance use, mental health and chronic pain conditions. Interoceptive training may facilitate well-being and support medication treatment for MOUD. This study examined the pre-post effects of the mindfulness-based intervention Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MOUD. MABT teaches interoceptive awareness skills to promote self-care and emotion regulation. Methods: People stabilized on medication for OUD (N = 303) from 6 community clinics in Northwestern United States were recruited and randomly assigned to MABT plus MOUD or MOUD only. In a mixed-methods study, we used an intent-to-treat approach to examine the proportion of days abstinent from non-prescribed opioids, and other substance use (primary outcomes) at baseline and 3 months post-intervention. Secondary outcomes included symptoms of mental health distress; emotional regulation difficulties; pain and physical symptom indicators; interoceptive awareness and mindfulness skills. Participant experience of MABT was collected through post-intervention surveys. Changes in outcomes were assessed using linear mixed models; content analysis was used to analyze the qualitative data. Results: Levels of overall substance use were low and did not differ between groups. Significant improvements in PTSD symptoms, interoceptive awareness, pain severity, pain activity interference, and physical symptom frequency were found for those who received MABT compared to MOUD only. Conclusion: In this stable MOUD population, substance use outcomes were not improved, however MABT demonstrated significant positive changes across multiple health outcomes critical for improving MOUD treatment. Clinical Trials Registration: NCT04082637 on 9/3/2019.

Trauma exposure across the lifespan among individuals engaged in treatment with medication for opioid use disorder: differences by gender, PTSD status, and chronic pain.

BACKGROUND: There is little study of lifetime trauma exposure among individuals engaged in medication treatment for opioid use disorder (MOUD). A multisite study provided the opportunity to examine the prevalence of lifetime trauma and differences by gender, PTSD status, and chronic pain. METHODS: A cross-sectional study examined baseline data from participants (N = 303) enrolled in a randomized controlled trial of a mind-body intervention as an adjunct to MOUD. All participants were stabilized on MOUD. Measures included the Trauma Life Events Questionnaire (TLEQ), the Brief Pain Inventory (BPI), and the Posttraumatic Stress Disorder Checklist (PCL-5). Analyses involved descriptive statistics, independent sample t-tests, and linear and logistic regression. RESULTS: Participants were self-identified as women (n = 157), men (n = 144), and non-binary (n = 2). Fifty-seven percent (n = 172) self-reported chronic pain, and 41% (n = 124) scored above the screening cut-off for PTSD. Women reported significantly more intimate partner violence (85%) vs 73%) and adult sexual assault (57% vs 13%), while men reported more physical assault (81% vs 61%) and witnessing trauma (66% vs 48%). Men and women experienced substantial childhood physical abuse, witnessed intimate partner violence as children, and reported an equivalent exposure to accidents as adults. The number of traumatic events predicted PTSD symptom severity and PTSD diagnostic status. Participants with chronic pain, compared to those without chronic pain, had significantly more traumatic events in childhood (85% vs 75%). CONCLUSION: The study found a high prevalence of lifetime trauma among people in MOUD. Results highlight the need for comprehensive assessment and mental health services to address trauma among those in MOUD treatment. TRIAL REGISTRATION: NCT04082637.

Collaborating to heal addiction and mental health in primary care (CHAMP): A protocol for a hybrid type 2a trial.

BACKGROUND: The gold-standard treatment for opioid use disorder (OUD) is medication for OUD (MOUD). However, less than a quarter of people with OUD initiate MOUD. Expanding the Collaborative Care Model (CoCM) to include primary care patients with OUD could improve access to and initiation of MOUD. This paper presents the methods and baseline sample characteristics of a Hybrid Type 2a trial comparing the effectiveness of CoCM for OUD and co-occurring mental health symptoms (MHS) to CoCM for MHS only. METHOD: 42 primary care clinics were cluster randomized and 254 primary care patients with OUD and elevated MHS were enrolled. Recruitment was terminated early by the Data and Safety Monitoring Board for futility. Participants completed research assessments at baseline, 3 months, and 6 months. The multiple primary outcomes were past-month number of days of nonmedical opioid use and SF12 Mental Health Component Summary (MCS) scores. RESULTS: MCS scores were over a standard deviation below the national mean (M = 34.5). Nearly half (47.6 %) of participants had previously overdosed in their lifetimes. Three quarters (76.0 %) were already being prescribed MOUD at baseline, only 30.4 % reported non-medical use of opioids, and only 33.9 % reported being bothered by opioid cravings. CONCLUSION: The unexpectedly high proportion of enrollees already prescribed MOUD at baseline indicates that most patients were in the maintenance rather than acute phase of treatment. Challenges identifying and enrolling patients in the acute phase of OUD treatment implies that intervention effectiveness will depend on its success preventing the discontinuation of MOUD rather than initiating MOUD.

Trauma Exposure Across the Lifespan among Individuals Engaged in Treatment with Medication for Opioid Use Disorder: Differences by Gender, PTSD Status, and Chronic Pain.

Background: There is little study of lifetime trauma exposure among individuals engaged in medication treatment for opioid use disorder (MOUD). A multisite study provided the opportunity to examine the prevalence of lifetime trauma and differences by gender, PTSD status, and chronic pain. Methods: A cross-sectional study examined baseline data from participants (N = 303) enrolled in a randomized controlled trial of a mind-body intervention as an adjunct to MOUD. All participants were stabilized on MOUD. Measures included the Trauma Life Events Questionnaire (TLEQ), the Brief Pain Inventory (BPI), and the Posttraumatic Stress Disorder Checklist (PCL-5). Analyses involved descriptive statistics, independent sample t-tests, and linear and logistic regression. Results: Participants were self-identified as women (n = 157), men (n = 144), and non-binary (n = 2). Fifty-seven percent (n = 172) self-reported chronic pain, and 41% (n = 124) scored above the screening cut-off for PTSD. Women reported significantly more intimate partner violence (85%) vs 73%) and adult sexual assault (57% vs 13%), while men reported more physical assault (81% vs 61%) and witnessing trauma (66% vs 48%). Men and women experienced substantial childhood physical abuse, witnessed intimate partner violence as children, and reported an equivalent exposure to accidents as adults. The number of traumatic events predicted PTSD symptom severity and PTSD diagnostic status. Participants with chronic pain, compared to those without chronic pain, had significantly more traumatic events in childhood (85% vs 75%). Conclusions: The study found a high prevalence of lifetime trauma among people in MOUD. Results highlight the need for comprehensive assessment and mental health services to address trauma among those in MOUD treatment. Trial Registration: NCT04082637.

Extended-release Naltrexone Is Not Linked to Hepatotoxicity in Adults Experiencing Homelessness and Alcohol Use Disorder.

OBJECTIVES: The use of extended-release naltrexone (XR-NTX) as treatment for alcohol use disorder (AUD) has been limited by a prior black box warning for hepatotoxicity. We performed a secondary analysis of data from a randomized clinical trial to compare serum liver enzyme levels for those randomized to XR-NTX versus placebo. METHODS: The parent study aimed to test the efficacy of combined pharmacobehavioral harm-reduction treatment in improving alcohol and quality-of-life outcomes for adults experiencing homelessness and AUD. We compared the 2 arms that received intramuscular injections of either 380 mg XR-NTX (n = 74) or placebo (n = 77). Outcomes included ( a ) liver enzyme levels and ( b ) liver enzyme values categorized as normal (<1× upper limit of normal [ULN]), elevated (1-3× ULN), or high (>3× ULN). We performed multinomial logistic regression and negative binomial generalized estimating equations modeling to assess the effects of treatment group and the time × treatment group interaction on liver enzyme outcomes. RESULTS: The mean age was 47.9 ± 9.9 years, and the mean baseline alcohol consumption was 23.2 ± 14.0 drinks per day. There were no significant differences in the development of liver enzyme elevations 1 to 3× ULN or more than 3× ULN (all P s > 0.25) or in the change in liver enzyme values (all P s > 0.41) between the placebo and the XR-NTX groups over the treatment course. CONCLUSIONS: In our study of adults experiencing homelessness and AUD, receipt of XR-NTX was not associated with hepatotoxicity. These findings support the use of XR-NTX to treat AUD even in patients who are drinking heavily and physiologically dependent on alcohol.

Integrating Opioid Use Disorder Treatment Into Primary Care Settings.

Importance: Medication for opioid use disorder (MOUD) (eg, buprenorphine and naltrexone) can be offered in primary care, but barriers to implementation exist. Objective: To evaluate an implementation intervention over 2 years to explore experiences and perspectives of multidisciplinary primary care (PC) teams initiating or expanding MOUD. Design, Setting, and Participants: This survey-based and ethnographic qualitative study was conducted at 12 geographically and structurally diverse primary care clinics that enrolled in a hybrid effectiveness-implementation study from July 2020 to July 2022 and included PC teams (prescribing clinicians, nonprescribing behavioral health care managers, and consulting psychiatrists). Survey data analysis was conducted from February to April 2022. Exposure: Implementation intervention (external practice facilitation) to integrate OUD treatment alongside existing collaborative care for mental health services. Measures: Data included (1) quantitative surveys of primary care teams that were analyzed descriptively and triangulated with qualitative results and (2) qualitative field notes from ethnographic observation of clinic implementation meetings analyzed using rapid assessment methods. Results: Sixty-two primary care team members completed the survey (41 female individuals [66%]; 1 [2%] American Indian or Alaskan Native, 4 [7%] Asian, 5 [8%] Black or African American, 5 [8%] Hispanic or Latino, 1 [2%] Native Hawaiian or Other Pacific Islander, and 46 [4%] White individuals), of whom 37 (60%) were between age 25 and 44 years. An analysis of implementation meetings (n = 362) and survey data identified 4 themes describing multilevel factors associated with PC team provision of MOUD during implementation, with variation in their experience across clinics. Themes characterized challenges with clinical administrative logistics that limited the capacity to provide rapid access to care and patient engagement as well as clinician confidence to discuss aspects of MOUD care with patients. These challenges were associated with conflicting attitudes among PC teams toward expanding MOUD care. Conclusions and Relevance: The results of this survey and qualitative study of PC team perspectives suggest that PC teams need flexibility in appointment scheduling and the capacity to effectively engage patients with OUD as well as ongoing training to maintain clinician confidence in the face of evolving opioid-related clinical issues. Future work should address structural challenges associated with workload burden and limited schedule flexibility that hinder MOUD expansion in PC settings.